Director of R&D, Product Development

Job Locations CA-Ottawa
ID
2020-1185
Category
Research & Development
Type
Regular Full-Time

Overview

The Director R&D, Product Development is responsible for the scientific aspects of product development and validation, the management of the product development R&D organization, and ensuring all stages of product development are conducted in compliance with DNA Genotek quality procedures.

Responsibilities

  • Project oversight and management of cross-functional deliverables and timelines.
  • Responsible for managing the design and execution of product development, validation testing and analysis of results.
  • Responsible for ensuring product development and validation activities are conducted according to DNA Genotek quality procedures and applicable regulations.
  • Responsible for Design Transfer to manufacturing
  • Manages staff of lab technologists, research associates and scientists utilizing DNA Genotek performance management system and good general management / leadership practices.
  • Works with Product Management, Project Management, Physical Design, Intellectual Property, Regulatory, Quality, and Research teams and other staff towards the complete and integrated development of saleable products.
  • Oversees and prepares experimental design for experiments.
  • Communicates study plans and outcomes to the DNA Genotek executive team.
  • Provides scientific guidance and support to staff members and all departments within DNA Genotek.
  • Ensures that priorities and deliverables are in alignment with DNA Genotek objectives.
  • Responsibility for content of scientific reports.
  • Provides product/technical support.
  • Prepares written protocols, white papers, and scientific papers, as applicable.
  • Regularly reviews scientific literature in areas of interest to the company and takes part in appropriate scientific conferences and trade shows.
  • Ensures smooth general operation of laboratory infrastructure (e.g. equipment, ordering/stocking of supplies)
  • Responsible for all laboratory registration, including biosafety.
  • Performs hands-on laboratory experimental work.
  • May assist in the preparation of patents and/or regulatory submissions arising from DNA Genotek research activities.
  • Other duties deemed appropriate for a Director R&D, Product Development.

Qualifications

  • Demonstrated experience leading research and development functions
  • Proven track record of successful product development in life science, genomics and/or molecular diagnostic companies as evidenced by commercial success.
  • Demonstrable technical skill and experience in the design and optimization of molecular assays, NGS applications, sample preparation, automation methodologies and microbiological techniques.
  • Significant experience in Design Control systems for product development and significant experience and understanding of FDA, EU and other global regulations and processes as applicable to new product development.
  • Demonstrated writing skills through publications, patents and grant writing within their field of expertise.
  • Strong people and project management skills.
  • Expertise with nucleic acid chemistry and metabolites is desired.
  • Familiar with principles of biological sample preservation.
  • Familiar with Design of Experiments process.
  • Proficient in troubleshooting experimental results.
  • Experience interacting with customers and presenting at conferences.
  • Strong project management, analytical and planning skills.
  • Proficiency in MS Office applications
  • Demonstrated aptitude towards effective management of people
  • Excellent verbal and written communication skills

EDUCATION AND/OR EXPERIENCE:

  • Ph.D. with specialization in Chemistry, Biochemistry, Molecular Biology, Microbiology, Biology, Genetics or other related degree or equivalent combination of relevant job experience and training.
  • 7+ years experience in industry R&D, or relevant experience
  • Demonstrated expertise in nucleic acid chemistry, nucleic acid extraction methodologies, and biological sample stabilization technologies, and experience working with nucleic acids (DNA/RNA/microRNA).
  • Experience working with metabolites would be an asset.
  • Experience in physical design and development of plastic parts desirable.
  • Experience presenting scientific findings to Executives as well as external conferences.
  • Experience developing IP and successful grant applications.
  • Expertise in FDA regulated environment and 510(k) clearance processes.

At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.

Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.

 

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